Chapter 3701:1-66 Radiation Generating Equipment

(1)
"Air kerma" means the sum of
the initial kinetic energy of all charged ionizing particles liberated by
uncharged ionizing radiation in a given mass of air. The unit for air kerma is
joules per kilogram which is given the special name of gray (Gy). To determine
air kerma in Gy from exposure in units of roentgens (R) multiply exposure by
the conversion factor 0.00876 Gy/R.

(3)
"Aluminum
equivalent" means the thickness of type 1100
aluminum alloy affording the same attenuation,
under specified conditions, as the material in question.

(4)
"Annual" means at least once a year, not
to exceed fourteen months.

(5)
"Automatic exposure control (AEC)" means a device which automatically controls
one or more technique factors in order to obtain, at a preselected location, a
required quantity of radiation.

(6)
"Beam-limiting device" means a collimator which provides a means to restrict
the dimensions of the x-ray field.

(7)
"C-arm
fluoroscope" means a fluoroscopic x-ray system in which the image receptor and
the x-ray tube housing assembly are connected or coordinated to maintain a
spatial relationship. Such a system allows a change in the direction of the
beam axis with respect to the patient without moving the
patient.

(8)
"Calibration"
means the determination of the
response or reading of an instrument relative to a series of known radiation
values over the range of the instrument, or the radiation output of a source of
radiation relative to a standard.

(9)
"Coefficient of variation" means the ratio of
the standard deviation to the mean value of the observations.

(10)
"Collimator" means a device or mechanism by
which the x-ray beam is restricted in size.

(11)
"Computed radiography" means a system that
utilizes a photostimulable phosphor (PSP) plate for capturing radiographic
images. The components of the system include, at a minimum, the PSP plate and a
computed radiography reader which laser scans the exposed plate, collects the
stimulated light and ultimately creates the digital image.

(15)
"CT noise" means the per cent standard
deviation of the fluctuations in CTN expressed as a percentage of the
attenuation coefficient of water.

(16)
"CT number (CTN)" means the number used
to represent the x-ray attenuation associated with each elemental area of the
CT image.

(17)
"Cumulative air kerma" means the total air kerma
accrued from the beginning of an examination or procedure and includes all
contributions from fluoroscopic and radiographic irradiation.

(18)
"Dead-man switch" means a switch so constructed
that a circuit closing contact can be maintained only by continuous pressure on
the switch by the operator.

(19)
"Direct scattered radiation," means
scattered radiation which has been deviated once in direction only by materials
irradiated by the useful beam.

(20)
"Enclosed system" means industrial radiation-generating equipment operated in
an enclosure or cabinet and may include, but is not limited to, cabinet
radiography, irradiation devices, and other equipment.

(21)
"Executive administration" means
individuals employed in the hospital's administration and
having the authority to expend capital funds, approve personnel actions, and
implement changes to hospital policy and procedure.

(27)
"Handler" means a facility that handles
radiation-generating equipment unless possession is solely for the purpose of
transportation.

(28)
"Hybrid imaging system" means a combination of systems
that separately produce anatomic and functional images in very close temporal
proximity without the need for patient repositioning and allow images to be
co-registered and fused. These systems may be used for purposes including, but
not limited to, attenuation correction, localization, registration, or fusion,
but not used independently for diagnosis.

(29)
"Image receptor" "means any device that
transforms incident x-ray photons into either a visible image or another form
that can be made into a visible image by further transformation. In those
cases, where means are provided to preselect a portion of the image receptor,
the term "image receptor" means the preselected portion of the
device.

(30)
"Individual
responsible for radiation protection (IRRP)" means an individual designated by
the registrant who has the knowledge and responsibility for overall radiation
safety and the quality assurance program at the facility, to include daily
radiation safety operations and compliance with the rules.

(e)
Chapter 4734. of the Revised Code to practice chiropractic medicine;
and

(f)
Chapter 4723. of the
Revised Code to practice as a clinical nurse specialist within the scope of
practice of his or her collaborating physician and in
accordance with the stadard care arrangement.

(g)
Chapter 4730. of the Revised Code to
practice as a physician assistant within the scope of practice of his or her
supervising physician and in accordance with the utilization plan approved by
the state medical board.

(37)
"Light field" means that area of the
intersection of the light beam from the beam-limiting device and one of the set
of planes parallel to and including the plane of the image receptor, whose
perimeter is the locus of points at which the illumination is one-fourth of the
maximum in the intersection.

(c)
Paragraph (C)(3) of rule
3701-83-52 of the Administrative
Code for CT equipment or paragraph (F)(3) of rule
3701-83-52 of the Administrative
Code for fluoroscopy at any facility providing CT or fluoroscopy services;
or

(d)
21 C.F.R.
900.12(a)(3) (as published
in the April 1, 2013, Code of Federal Regulations) for any
facility providing mammography services.

(48)
"Radiation-generating equipment (RGE)" means any
manufactured product or any component of such a product or device, or any
machine or system that during operation can generate or emit ionizing
radiation, except those that emit ionizing radiation only from
radioactive material. The system includes, minimally, an x-ray high voltage
generator, an x-ray control, a tube housing assembly, a beam-limiting device,
and the necessary supporting structures. "Radiation-generating equipment" does
not include either of the following:

(b)
Microwave ovens including food service microwave ovens used for commercial and
industrial uses, television receivers, electric lamps, and other appliances and
products such as computer monitors that generate very low levels of
radiation.

(49)
"Radiation worker" means an individual engaged
in activities registered by the department and controlled by the
registrant.

(50)
"Reference plane" means a plane which is
displaced from and parallel to the computed tomographic plane.

(51)
"Scan" means the complete process of collecting
x-ray transmission data for the production of a tomogram. Data can be collected
simultaneously during a single scan for the production of one or more
tomograms.

(52)
"Scan sequence" means a pre-selected set of two
or more scans performed consecutively under pre-selected CT conditions of
operation.

(53)
"Scattered
radiation" means radiation that, during passage through matter, has been
deviated in direction.

(60)
"Table increment" means the amount of relative
displacement of the patient with respect to the CT x-ray system between
successive scans measured along the direction of such
displacement.

(61)
"Technique
factors" means any combination of the following which determines the exposure
rate: kVp, mA, time, x-ray pulses, or the product of tube current and exposure
time in mAs.

(62)
"Tomogram" means
the depiction of the radiation attenuation properties of a section through a
body.

(63)
"Tomographic
plane" means that geometric plane which is identified as corresponding to the
output tomogram.

(64)
"Tube housing assembly" means the tube housing
with tube installed. It includes high voltage or filament transformers and
other appropriate elements when they are contained within the tube
housing.

(65)
"Useful beam"
means that part of the radiation which passes through the window, aperture,
cone, or other collimating device of the source housing.

(66)
"Visible area"
means that portion of the input surface of the image receptor over which
incident x-ray photons are producing a visible image.

(67)
"X-ray field" means that area of the
intersection of the useful beam and any one of the set of planes parallel to
and including the plane of the image receptor, whose perimeter is the locus of
points at which the air kerma rate is one-fourth of the maximum in
the intersection.

As used in this rule, "radiation-generating equipment" means
radiation-generating equipment, other than
therapeutic
radiation-generating equipment,
used for dental, veterinary, or medical purpose.
Handlers of
this equipment shall comply with the following:

(A)
The director may, upon application
thereof or upon his or her own initiative, grant a variance to the requirements
of rules in this chapter as he or she determines is authorized by law, provided
that the registrant shows to the satisfaction of the director that there is
good cause for the variance, and that the variance will not result in any undue
hazard or effect on the public health and safety or environment. The terms,
conditions, and expiration of the variance shall be set forth in writing by the
director. Failure to comply with the terms of the variance may result in
immediate revocation of the variance.

(B)
No individual
shall be exposed to the useful beam except a patient for
dental or medical radiologic procedures and unless such exposure has been
authorized by a licensed practitioner within his or her scope of practice. This
provision specifically prohibits deliberate exposure for the following
purposes:

(1)
Exposure of
an
individual for training, demonstration, or other
non-medical
purpose; and

(2)
Exposure of an individual for the purpose of
self-referred screening except as authorized by the department in accordance
with paragraph (C) of this rule.

(C)
Any person proposing to conduct a
self-referral screening program using radiation-generating equipment shall not
initiate such a program without prior approval by the department. When
requesting such approval, that person shall submit information on a form
prescribed by the department. If any information submitted to the department
becomes invalid or not current, the department shall be immediately notified in
writing.

(D)
The department may use
interview or observation to determine that the handler assures:

(1)
Every individual who performs radiologic
procedures on human beings holds the appropriate radiologic license as required
by Chapter 3701-72 of the Administrative Code and Chapter
4715. of the Revised Code; and

(2)
Every individual who is licensed to
perform radiologic procedures is adequately instructed in the registrant's safe
operating procedures and can demonstrate competency in the safe use of the
equipment.

(E)
Any
radiation-generating equipment that does not meet the provisions set forth in
this rule or any other applicable equipment requirements of Chapter 3701:1-66
of the Administrative Code shall not be used to irradiate
patients unless the director or a radiation expert determines that the
non-compliance will not pose a radiation risk and arrangements have been made
to promptly correct the non-compliance.

(F)
Radiation-generating
equipment shall bear a warning label on the control panel, by the exposure switch or by the main power switch
which cautions individuals that radiation is produced when it is
energized.

(1)
On battery-powered
x-ray generators, visual means shall be provided on the control panel to
indicate whether the battery is in a state of charge adequate for proper
operation.

(2)
The leakage
radiation from the diagnostic source assembly measured at a distance of one
meter in any direction from the source shall not exceed 0.88 milligray air
kerma (one hundred milliroentgen exposure) in one hour when the x-ray tube is
operated at its leakage technique factors. Compliance shall be determined by
measurements averaged over an area of one hundred square centimeters with no
linear dimension greater than twenty centimeters;

(3)
Except for mammographic
radiation-generating equipment, the half-value layer (HVL) of the useful beam
for a given x-ray tube potential shall not be less than the values shown in
table 1. If it is necessary to determine such HVL at an x-ray tube potential
which is not listed in table 1, linear interpolation or extrapolation may be
made.

Table 1.

X-Ray Tube Voltage (kilovolt peak)

Minimum HVL (millimeter of aluminum)

Designed

Measured

Specified

I - Other

II - Other

Operating Range

Operating

Dental

X-Ray

X-Ray

Potential

Systems1

Systems2

Systems3

Below 51

30

1.5

0.3

0.3

40

1.5

0.4

0.4

50

1.5

0.5

0.5

51 to 70

51

1.5

1.2

1.3

60

1.5

1.3

1.5

70

1.5

1.5

1.8

Above 70

71

2.1

2.1

2.5

80

2.3

2.3

2.9

90

2.5

2.5

3.2

100

2.7

2.7

3.6

110

3.0

3.0

3.9

120

3.2

3.2

4.3

130

3.5

3.5

4.7

140

3.8

3.8

5.0

150

4.1

4.1

5.4

1 Dental x-ray systems
designed for use with intraoral image receptors and manufactured after December
1, 1980.

2 Dental x-ray systems
designed for use with intraoral image receptors and manufactured before or on
December 1, 1980, and all other x-ray systems subject to this section and
manufactured before June 10, 2006.

3 All x-ray systems, except
dental x-ray systems designed for use with intraoral image receptors, subject
to this section and manufactured on or after June 10, 2006.

(a)
For capacitor
energy storage equipment, compliance with the requirements of this paragraph
shall be determined with the system fully charged and a setting of ten
milliampere-seconds (mAs) for each exposure; and

(b)
The required minimal HVL of the useful
beam shall include the filtration contributed by all materials which are
permanently between the source and the patient.

(4)
For x-ray systems which have variable
kilovolt peak (kVp) setting and variable filtration for the useful beam, a
device shall link the kVp selector with the filter and shall prevent an
exposure unless the minimum amount of filtration necessary to produce the HVL
required by paragraph (G)(3) of this rule is in the useful beam for the given
kVp which has been selected.

(5)
Where two or more x-ray tubes are controlled by one exposure switch, the tube
that has been selected shall be clearly indicated prior to initiation of the
exposure. This indication shall be both on the x-ray control panel and
for dental equipment at or near the selected tube
housing assembly.

(6)
The x-ray
tube housing assembly supports shall be adjusted such that the tube housing
assembly will remain stable during an exposure unless tube housing movement is
a designed function of the radiation-generating equipment.

(7)
The technique factors to be used during
an exposure shall be indicated before the exposure begins. If automatic
exposure controls are used, the technique factors which are set prior to the
exposure shall be indicated. This requirement may be met by permanent markings
on equipment having fixed technique factors. Indication of technique factors
shall be visible from the operator's position except in the case of spot films
taken during fluoroscopy procedures or dental intraoral or panoral
films.

(8)
All position locking,
holding, and centering devices on radiation-generating equipment components
shall function as designed by the manufacturer.

(H)
In addition to other applicable radiation
safety rules in Chapter 3701:1-66 of the Administrative Code, handlers of
radiation-generating equipment shall meet the following radiation safety
requirements:

(1)
Software-based technique selections, a chart, or a combination of the two shall be provided in the
vicinity of the radiation-generating equipment's control panel which specifies,
for examinations performed with that system, the following information:

(a)
Patient's body part, radiographic
projection, anatomical size or age
, and the
technique factors to be utilized for each;

(2)
Gonadal shielding of not less than 0.5
millimeter lead equivalent material shall be used for human patients, who have
not passed the reproductive age, during radiologic procedures in which the
gonads are in the useful beam, except for cases in which this would interfere
with the radiologic procedure.

(3)
Except for patients who cannot be moved out of
the room, only the staff, ancillary personnel or other persons required for the
medical procedure or training shall be in the room during the radiologic
procedure. Other than the patient being examined:

(a)
All individuals shall be positioned such
that no part of the body shall be struck by the useful beam unless protected by
not less than 0.5 millimeter lead equivalent material;

(b)
The x-ray operator, other staff,
ancillary personnel, and other persons required for the medical procedure shall
be protected from the direct scatter radiation by protective aprons or whole
body protective barriers of not less than 0.25 millimeter lead equivalent
material; and

(c)
Human patients
who cannot be removed from the room shall be protected from the direct scatter
radiation by whole body protective barriers of not less than 0.25 millimeter
lead equivalent material or shall be so positioned that the nearest portion of
the body is at least two meters ( 6.5 feet) from both the tube head and the
nearest edge of the image receptor.

(4)
If performing a radiologic procedure requires
auxiliary support for holding a patient or an image receptor, the handler shall
ensure the following:

(a)
Mechanical holding
devices shall be used when the procedure permits their use in lieu of having an
individual hold the patient or image receptor;

(b)
Written safe operating procedures
required by paragraph (B)(4) of rule 3701:1-66-04 of
the Administrative Code shall indicate the requirements for selecting
someone to hold a patient or image receptor, and the procedure that shall be
followed. All individuals holding a patient or image receptor during radiation
exposures shall be at least eighteen years of age; and

(5)
The facility shall have protective aprons and
gloves available in sufficient numbers to provide protection to anyone who is
involved with x-ray operations.

(6)
Any radiation worker participating in
fluoroscopic, veterinary, or mobile or portable x-ray procedures shall be
required to wear an individual monitoring device unless the registrant
demonstrates it is unlikely the radiation worker will receive in excess of the
doses specified in paragraphs (B)(1)(a) to (B)(1)(c) of rule
3701:1-38-14 of the
Administrative Code.

(7)
The entrance air
kerma resulting from the technique used for the specified average adult patient
for routine diagnostic radiography shall not exceed the values listed in table
2. The entrance air kerma resulting from the technique used for routine
intraoral bitewing exams shall not exceed the values listed in table 3. All
values of entrance air kerma are specified as free-in-air, without backscatter.
The corresponding entrance exposure in milliroentgens is listed in parentheses.
Linear extrapolation or interpolation shall be used for an x-ray tube potential
(kVp) not listed in table 3.

(8)
Procedures and auxiliary equipment designed to
minimize patient and radiation worker exposure shall be utilized as follows:

(a)
For facilities utilizing radiographic
film, the speed of the screen and film combinations used shall be the fastest
speed consistent with the diagnostic objective of the examinations. Film
cassettes without intensifying screens shall not be used for any routine
diagnostic radiography, with the exception of veterinary and specimen
radiography;

(b)
Radiation-generating equipment subject to rule
3701:1-66-05 of the
Administrative Code shall not be utilized in procedures where the
source-to-skin distance (SSD) is less than thirty centimeters, except for
veterinary x-ray systems;

(c)
If
grids are used between the patient and the image receptor to decrease scatter
to the image receptor and improve contrast, the grid shall be:

(i)
Properly aligned, with the x-ray tube
side facing the correct direction, and the grid centered to the central ray;
and

(9)
Except for radiation-generating equipment used
for veterinary, portable, dental panoral, dental intraoral, lithotripsy, or
bone densitometry applications, the operator shall stand behind a protective
barrier, either in a separate room, in a protected booth, or behind a
shield.

(ii)
For
new radiation-generating equipment installations which might cause a
significant increase in radiation hazard.

(b)
Prior to patient use, handlers shall utilize a radiation expert
to determine
compliance with exposure levels in accordance with rule
3701:1-38-14 of the
Administrative Code by performing:

(i)
An area
radiation survey for new installation of radiation-generating
equipment .

(ii)
An area
radiation survey for reinstallation or after any change in
structural shielding unless, in the documented determination of a radiation
expert, the reinstallation or change will not cause a significant increase in
radiation hazard.

(iii)
A re-calculation of an area radiation survey results
after an increase in the clinical workload that exceeds the assumptions used in
the existing radiation survey.

(c)
Notwithstanding
paragraph (I)(1)(b)(ii) of this rule, reinstallations of radiation-generating
equipment of the same operating parameters, location and geometry does not
require another survey as long as the previous documented area radiation survey
is maintained and available for inspection.

(d)
The individual responsible for radiation
protection shall obtain a written report of the shielding design and the area radiation survey
. A copy of the
report shall be made available to the department's
inspector upon request.

(2)
Handlers shall assure that no individual
operates or permits the operation of radiation-generating equipment unless
structural shielding and protective barriers are used such that no person other
than the patient being examined shall receive a total effective dose equivalent
in excess of the limits prescribed in rules
3701:1-38-12 and
3701:1-38-13 of the
Administrative Code.

(3)
Handlers
shall provide a protective barrier either in a separate room, in a protected
booth, or use a mobile barrier that will intercept the useful beam and any
direct scattered radiation.

(4)
Handlers shall provide a window of lead equivalency affording protection equal
to that required by the adjacent barrier, a television monitoring system, or a
mirror system large enough and so placed that the operator can see the patient
without having to leave the protected area during exposure.

(5)
Handlers of
stationary CT and mobile CT radiation-generating equipment used in one place
shall assure the facility design provides for two-way aural communications
between the patient and operator.

(J)
In addition to all applicable rules in
Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating
equipment shall meet the following quality assurance requirements:

(1)
X-ray systems and associated components
used on humans and certified pursuant to 21 C.F.R. part 1020 (as published in
the April 1, 2013 Code of Federal Regulations) shall be maintained
in compliance with applicable requirements of that standard, and handlers shall
maintain documentation of compliance between inspections.

(2)
The handler shall maintain the following
information for all radiation-generating equipment for inspection
by the department:

(b)
Records of surveys, calibrations,
maintenance, and modifications performed on the radiation-generating equipment
which shall be maintained between inspections; and

(c)
A copy of all correspondence with the
department regarding each piece of radiation-generating equipment.

(3)
Unless otherwise specified in
another rule in this chapter, each installation using a piece of
radiation-generating equipment and using analog image receptors, such as
radiographic film, shall have available suitable equipment for handling and
processing radiographic images in accordance with the following provisions:

(ii)
The temperature of solutions in the
tanks shall be maintained within the range of 15.6 to 26.7 degrees celsius
(sixty to eighty degrees Fahrenheit). Film shall be developed in accordance
with the time-temperature relationships recommended by the film manufacturer,
or, in absence of such recommendations, with the following time-temperature
chart:

Time-Temperature Chart

Thermometer Reading (Degrees)

Minimum Developing Time (Minutes)

°C

°F

26.7

80

2

26.1

79

2

25.6

78

2.5

25.0

77

2.5

24.4

76

3

23.9

75

3

23.3

74

3.5

22.8

73

3.2

22.2

72

4

21.7

71

4

21.1

70

4.5

20.6

69

4.5

20.0

68

5

19.4

67

5.5

18.9

66

5.5

18.3

65

6

17.8

64

6.5

17.2

63

7

16.7

62

8

16.1

61

8.5

15.6

60

9.5

(iii)
Devices shall be utilized which will indicate the actual temperature of the
developer and signal the passage of a preset time appropriate to the developing
time required;

(i)
Films shall be developed in accordance
with the time-temperature relationships recommended by the film manufacturer;
in the absence of such recommendations, the film shall be developed using the
following chart:

Developer Temperature (Degrees)

Minimum Immersion Timea/
(Seconds)

°C

°F

Seconds

35.5

96

19

35

95

20

34.5

94

21

34

93

22

33.5

92

23

33

91

24

32

90

25

31.5

89

26

31

88

27

30.5

87

28

30

86

29

29.5

85

30

a/Immersion time only, no
crossover time included.

(ii)
The specified developer temperature and immersion time shall be posted in the
darkroom, on the automatic processor, or be readily available to the operator;
and

(c)
Processing
deviations from the requirements listed above shall be documented by the
handler in such manner that the requirements of this rule are shown to be met
or exceeded, such as with extended processing, and special rapid chemistry.

(d)
Film processing solutions
shall be prepared in accordance with the directions given by the film
manufacturer, and shall be maintained in strength by replenishment or renewal
so that full development is accomplished within the time specified by the
manufacturer.

(4)
Pass
boxes, if provided, shall be so constructed as to exclude light from entering
the darkroom when cassettes are placed in or removed from the boxes, and shall
incorporate adequate shielding from stray radiation to prevent exposure of
undeveloped film.

(5)
The darkroom
shall be light tight and use proper safelighting such that any film which would
produce an optical density between one and two when exposed in a cassette to
x-radiation and then processed shall:

(a)
Not
suffer an increase in optical density greater than 0.1 when exposed in the
darkroom for two minutes with all safelights on; and

(b)
Not suffer an increase in optical density
greater than 0.05 for mammography when exposed to the darkroom for two minutes
with all safelights on.

(6)
Darkrooms typically used by more than one
individual shall provide a method to prevent accidental entry of light while
undeveloped films are being handled or processed.

(7)
Film shall be stored in a cool, dry place
and shall be protected from exposure to stray radiation. Film in open packages
shall be stored in a light-tight container. If used, daylight film handling
boxes shall preclude fogging of the film.

(c)
Replaced as
necessary to assure radiographs of good diagnostic quality.

(10)
For those registrants
employing computed radiography imaging systems, the following shall apply:

(a)
If the computed radiography reader is
located in the same room as the radiation-generating equipment and it is not
behind a protective barrier, x-ray exposures shall not be made during
processing;

(b)
Computed
radiography plates shall be processed as soon as possible after exposure, not
to exceed eight hours under any circumstances; and

(c)
Computed radiography plates shall be
adequately shielded from stray radiation. Registrants shall develop a process
that will ensure that computed radiography plates are used frequently enough or
erased so as to produce diagnostic quality images.

(B)
An individual seeking certification or
renewal of certification as a radiation expert shall apply to the department on
a form prescribed and provided by the director. The application shall contain
at least the following:

(3)
A non-refundable check, electronic
payment, or money order payable to "treasurer, state of Ohio" for the
appropriate certification fee in the amount of one hundred dollars for each
category specified in paragraph (A) of this rule;

(4)
Evidence that the applicant has
appropriate training and qualifications to perform oversight and maintenance of
quality assurance programs required by division (A) of section
3748.13 of the Revised Code for
the category for which the applicant is applying as set forth in paragraphs (C)
to (E) of this rule; and

(4)
A master's
or doctor's degree in physics, medical physics, other physical science,
engineering, or applied mathematics from an accredited college or university;
and

(a)
Have completed one year of full time
training in medical physics and an additional year of full time work experience
under the supervision of a board certified medical physicist who meets the
qualifications of paragraph (C)(1), (C)(2) or (C)(3) of this rule at a medical
institution. This training and work experience shall be conducted in clinical
radiation facilities that provide high-energy external beam radiation therapy
with photons and electrons with energies greater than or equal to one MV or one
MeV;

(b)
The individual shall have
performed the applicable tasks listed in rules
3701:1-67-03 to
3701:1-67-06 of the
Administrative Code under the supervision of a qualified medical physicist
during the year of work experience; and

(c)
Obtain certification pursuant to
paragraph (C)(1), (C)(2), or (C)(3) of this rule within five years after the
effective date of this rule.

(D)
An applicant for radiation expert
certification for the category of diagnostic radiation-generating equipment
shall have at least one of the following:

(1)
Certification by the "American Board of Radiology" in radiological physics or
diagnostic radiological physics;

(2)
Certification by the "American Board of
Medical Physics" in medical physics with a specialty in diagnostic imaging
physics;

(3)
A master's degree or
doctorate from an accredited college or university in physics, biophysics,
medical physics, radiological physics or health physics, or mechanical,
electrical, or nuclear engineering, or applied mathematics with a minor in
physics; and three years of experience within the five years prior to the date
of application under the direct supervision of a certified individual as
provided in paragraph (D)(1) or (D)(2) of this rule or a radiation expert
certified in diagnostic radiation-generating equipment in developing and
performing oversight of quality assurance for diagnostic radiation-generating
equipment.

(E)
An
applicant for radiation expert certification for the category of mammography
radiation-generating equipment shall have at least one of the following:

(1)
Certification by the "American Board of
Radiology" in radiological physics or diagnostic radiological
physics;

(2)
Certification by the
"American Board of Medical Physics" with a specialty in diagnostic imaging
physics;

(3)
A master's degree or
higher in a physical science from an accredited college or university, and at
least the following:

(c)
Have the experience of
conducting surveys of at least ten mammography x-ray units under the direct
supervision of a certified individual as provided in paragraph (E)(1) or (E)(2)
of this rule or a radiation expert certified in mammography.

(F)
The department may
return an incomplete application for certification or certification renewal.
The applicant shall respond to the director's request for additional
information within twenty days of receiving the request.

(G)
A certificate issued under this rule
shall expire two years after the date of its issuance and may be renewed in
accordance with the standard renewal procedures established in Chapter 4745. of
the Revised Code. On or before thirty days prior to the expiration of a
certificate, the department shall mail a notice and application for renewal to
the certificate holder. The certificate holder shall complete the application
and return it to the treasurer of state with the certification renewal fee in
the form of a check, electronic payment, or money order payable to "treasurer,
state of Ohio," in the amount of one hundred dollars for each category
specified in paragraph (A) of this rule.

(H)
Within sixty days of receiving a complete
application for certification or certification renewal, the director shall,
pursuant to Chapter 119. of the Revised Code, either issue a certification or
certification renewal or, deny the application, or the director may at any time
suspend or revoke a certification if the applicant or certificate holder:

(1)
Does not meet the applicable requirements
specified in this rule for attaining and maintaining certification as a
radiation expert;

(2)
Previously
had a radiation expert certificate revoked or currently has a certificate
suspended pursuant to this paragraph;

(3)
Has provided services for a category of
radiation-generating equipment that is not identified on his or her radiation
expert certificate;

(4)
Misrepresents the types of quality assurance programs for which he or she is
certified to provide services or otherwise has provided services for which he
or she was not certified to provide;

(5)
Misrepresents information on the
application or has misrepresented an audit report filed with the director
pursuant to rule
3701:1-66-04 of the
Administrative Code;

(6)
Has
submitted an audit report to the director that the radiation expert did not
personally perform or supervise the individual assisting in the performance of
quality assurance tests;

(7)
Does
not respond to the request for additional information within twenty days of
receiving the request as provided in paragraph (F) of this rule;

(8)
Does not comply with paragraphs (C) to
(E) of this rule, as applicable, in which case the director shall deny the
application only for that certification for the affected category of
radiation-generating equipment;

(2)
A
change in the name, address, or phone number of the radiation expert;

(3)
A change to the listing of hospitals in
which the radiation expert is designated as CRE; and

(4)
Any other change that would render an
application or certificate no longer accurate.

(J)
The individual certified as a radiation
expert shall provide the director upon request with any other information
regarding the requirements set forth in this rule.

(K)
Each certified radiation expert shall
obtain continuing education for each certification period in accordance with
the following:

(1)
Certified radiation experts
having certification in one category specified in paragraph (A) of this rule
shall obtain fifteen hours of continuing education pertaining to the category
of certification;

(2)
Certified
radiation experts having certification in two categories specified in paragraph
(A) of this rule shall obtain twenty hours of continuing education pertaining
to one or both categories of certification; and

(3)
Certified radiation experts having
certification in three categories specified in paragraph (A) of this rule shall
obtain twenty-five hours of continuing education pertaining to one or more
categories of certification.

(L)
Continuing education programs are subject
to approval by the director.

(M)
A
certified radiation expert who provides instruction in a continuing education
program related to radiation safety is eligible to claim up to five hours of
instruction time for the required continuing education for his or her
certification period.

(N)
In
accordance with section
3748.12 of the Revised Code, a
certification renewal fee that remains unpaid on the
ninety-first day after the original invoice date shall be assessed an
additional amount equal to ten per cent of the original fee.

(O)
Application for the same certification category may be denied after the
expiration date of the previous certification for individuals who do not renew
their certification according to this rule, and who do not provide written
notification that they no longer require or want certification in that
category.

(P)
If an individual
allows his or her certification to expire and the individual applies for the
same certification within one year following the expiration of that
certification, the individual shall submit evidence of completing the
continuing education requirements provided in this rule.

(A)
Each registrant shall
develop, implement and maintain a written quality
assurance program. For purposes of this chapter and
Chapter 3701:1-67 of the Administrative Code, quality assurance program
means a program providing for verification by written procedures such as
testing, auditing, and inspection to ensure that deficiencies, deviations,
defective equipment, or unsafe practices, or a combination thereof, relating to
the use, disposal, management, or manufacture of radiation devices are
identified, promptly corrected, and reported to the appropriate regulatory
authorities.

(B)
The
written quality assurance program of each
registrant shall address and include records to verify implementation of at least
the following:

(1)
The intervals of and
procedures for the evaluation of all radiation-generating equipment to ensure
compliance with all applicable rules of this chapter;

(2)
Procedures for maintaining compliance with
occupational and public exposure limits;

(3)
Procedures for notifying the director
when individuals are occupationally over-exposed to radiation, pursuant to
Chapter 3701:1-38 of the Administrative Code;

(4)
Safe operating procedures for each
type of radiation-generating equipment to be handled;

(5)
Training of operators of each type of
radiation-generating equipment to be handled in order to assure competency in
the operating procedures;

(6)
In
addition to the requirements of paragraph (B)(1) of rule
3701:1-38-10 of the
Administrative Code, individuals likely to receive an annual occupational dose
in excess of one millisievert (one hundred millirem) shall
be instructed in the following:

(b)
A description
of the radiation-generating equipment and its location;

(7)
The quality control tests to be
performed, the frequency of the quality
control tests to be performed and the personnel
responsible for the performance of the quality control tests as
applicable to the radiation-generating equipment type and use;

(8)
Policies regarding the state
licensure or
certification of each person operating radiation-generating equipment as
required by Chapters 4773. and 4715. of the Revised Code;

(9)
The dissemination of
quality assurance policies and a method to educate
affected
workers on those policies and any policy
changes;

(10)
Radiation workers'
role and responsibility for following and supporting the quality assurance
program;

(11)
Policies regarding
personnel protection, including time, distance, and shielding;

(2)
Employees working in the radiation areas
shall be made aware of the identity, scope of authority, and a method for
contacting the certified radiation expert and the individual responsible for
radiation protection. This information, or a specific location where this
information may be obtained, shall be conspicuously posted in each area where
radiation-generating equipment is used.

(3)
Each hospital registrant shall establish
a quality assurance committee for the management of the quality assurance
program. The members of the
quality assurance committee shall be approved by an executive administrator.
Committee meetings may be attended by the members or similarly qualified,
designated alternates. The quality assurance committee shall include at
least the following members:

(e)
A management
representative of each department of the hospital which has responsibilities
involving the handling of radiation-generating equipment.

(4)
The quality assurance committee shall
meet as often as is deemed necessary to carry out its duties, but at least on a
quarterly basis. To establish a quorum at least one-half of the committee's
membership must be present either in person or by
telecommunication means, and must include the individual responsible for
radiation protection for the hospital, and the member of the executive
administration of the hospital. In addition, each
member must attend at least one quarterly meeting each calendar year. A
record of each meeting shall be maintained and distributed to each
member which shall include the
following:

(d)
Radiation-generating equipment performance evaluation
summaries to include a description of any issues
found; and

(e)
Any
corrective actions
recommended by the certified radiation expert
necessary to comply with the requirements of this chapter.

(6)
The quality assurance program shall be
audited at least annually as defined in paragraph (A)( 18) of rule
3701:1-38-01 of the
Administrative Code by a certified radiation expert. The certified radiation
expert shall develop a written report of the audit findings on forms prescribed
by the director and submit the report to the quality assurance committee within
thirty days of completing the audit. The quality assurance committee shall
review the audit report and implement any corrective actions determined to be
necessary. The certified radiation expert shall file the audit report with the
director within ninety days of completing the audit. Every audit report shall
include a determination of whether the quality assurance program properly
addresses the matters described in this rule and whether it is being carried
out in accordance with the written quality assurance program, and any
corrective actions to be taken to comply with the requirements of this chapter.
The audit report shall become a part of the inspection record.

(D)
At the time of the state
inspection the following items shall be readily available for review:

(1)
A complete listing of the inventory of
radiation-generating equipment, including the location and description of each
unit;

(2)
The
written quality assurance program as
required by this rule shall be
maintained in the form of a readily available manual or manuals, either in hard
copy printed format or electronic format;

(3)
Data and test results of the evaluation
of each unit of radiation-generating equipment and its shielding and
surroundings;

(5)
Current copies of department's licensure
verification web page for each individual who is required to possess a license
at the facility; and

(6)
Instrumentation
used to perform area radiation surveys, calibrations and evaluations, as
appropriate for each type of radiation-generating equipment, including at least
biennial calibration certificates or cross-calibration documentation done
within the biennium.

As used in this rule, "radiographic
equipment" means radiation-generating equipment that is operated for medical
use. The requirements of this rule do not apply to radiation-generating
equipment used for dental intraoral or panoral, mammography, bone densitometry,
computed tomography, fluoroscopy or spot film imaging, and radiation therapy
simulators. In addition to other applicable rules contained in Chapters
3701:1-38 and 3701:1-66 of the Administrative Code, handlers of radiographic
equipment shall comply with the following:

(1)
A means shall be
provided for limiting the x-ray beam to the image receptor and area of clinical
interest.

(2)
For radiographic equipment having a variable x-ray
field limitation device, the limitation device shall have means for independent
stepless adjustment of both the length and width of the x-ray
field.

(3)
For radiographic equipment that employs a light field
for visually defining the perimeter of the x-ray field, the light source shall
be functional and the total misalignment of the edges of the visually defined
field with the respective edges of the x-ray field along either the length or
width of the visually defined field shall not exceed two per cent of the
source-to-image distance (SID).

(4)
In addition to
the requirements of paragraphs (A)(1), (A)(2) and (A)(3) of this rule
stationary radiographic equipment having a variable x-ray field limitation
device shall have:

(a)
A means provided to indicate when the axis of the
x-ray beam is perpendicular to the plane of the image receptor;

(b)
A means provided
to align the center of the x-ray field with respect to the center of the image
receptor to within two per cent of the SID, when the x-ray beam is
perpendicular to the plane of the image receptor;

(c)
A means to
indicate the SID to within two per cent. If it is a fixed SID, the distance
shall be indicated with a permanent marking;

(d)
The beam
limiting device indicate numerically the field size in the plane of the image
receptor to which it is adjusted and be accurate within two per cent of the
SID; and

(e)
Compliance measurements made to discrete SID's and
image receptor dimensions in common clinical use, or at any other specific
dimensions at which the beam-limiting device or its associated diagnostic x-ray
system is uniquely designed to operate.

(5)
Radiographic
equipment designed with only one image receptor size at a fixed SID shall
have:

(a)
A
means to limit the field at the plane of the image receptor to dimensions no
greater than those of the image receptor, and to align the center of the x-ray
field with the center of the image receptor within two per cent of the SID;
or

(b)
A means to align the field such that the x-ray field
at the plane of the image receptor shall not extend beyond any edge of the
image receptor.

(a)
A
means to limit the x-ray field in the plane of the receptor so that such field
does not exceed each dimension of the image receptor by more than two per cent
of the SID when the axis of the x-ray beam is perpendicular to the plane of the
image receptor;

(b)
A means to align the center of the x-ray field with
the center of the image receptor to within two per cent of the SID or for
equipment uniquely designed where the beam axis is intended to be offset from
the center of the image receptor, the x-ray field at the plane of the image
receptor shall not extend beyond the image receptor; and

(c)
Paragraphs(A)(6)(a) and (A)(6)(b) of this rule may be met with either:

(i)
An assortment of
removable, fixed-aperture, beam limiting devices sufficient to meet the
requirement for each combination of image receptor size and SID for which the
unit is designed with each such device having clear and permanent markings to
indicate the image receptor size and SID for which it is designed;
or

(ii)
A beam-limiting device having multiple fixed apertures
sufficient to meet the requirement for each combination of image receptor size
and SID for which the unit is designed. Permanent, clearly legible markings
shall indicate the image receptor size and SID for which each aperture is
designed and shall indicate which aperture is in position for
use.

(7)
If a positive
beam limitation, (PBL) device is used, it shall meet the following additional
requirements:

(a)
The PBL shall prevent the production of x-rays when
any of the following conditions are met:

(i)
Either the
length or width of the x-ray field in the plane of the image receptor differs
from the corresponding image receptor dimensions by more than three per cent of
the SID, except as permitted by paragraph (A)(7)(c) of this
rule;

(ii)
The sum of the length and width differences as stated
in paragraph (A)(7)(a)(i) of this rule without regard to sign exceeds four per
cent of the SID; or

(iii)
The beam-limiting device is at an SID for which PBL is
not designed for sizing;

(b)
Compliance with
paragraph (A)(7)(a) of this rule shall be determined:

(i)
When the
equipment indicates that the beam axis is perpendicular to the plane of the
image receptor; and

(ii)
No sooner than five seconds after insertion of the
image receptor;

(c)
The PBL system
shall be capable of operation, at the discretion of the operator, such that the
size of the field may be made smaller than the size of the image receptor
through stepless adjustment of the field size. The minimum field size at a SID
of one hundred centimeters shall be equal to or less than five centimeters by
five centimeters;

(d)
The PBL system shall be designed such that if a change
in image receptor does not cause an automatic return to PBL function as
described in paragraph (A)(7)(a) of this rule, then any change of image
receptor size or SID must cause an automatic return; and

(e)
The PBL system
shall function as described in paragraph (A)(7) of this rule whenever all the
following conditions are met:

(i)
The image receptor is inserted into a permanently
mounted cassette holder;

(ii)
The image receptor length and width are less than
fifty centimeters;

(iii)
The x-ray beam axis is within plus or minus three
degrees of vertical in any direction and the SID is ninety to one hundred
thirty centimeters inclusive; or the x-ray beam axis is within plus or minus
three degrees of horizontal and the SID is ninety to two hundred five
centimeters inclusive;

(iv)
The x-ray beam axis is perpendicular to the plane of
the image receptor to within plus or minus three degrees; and

(b)
It shall not be possible to initiate an exposure when
the timer is set to the "zero" or "off" position if either position is
provided; and

(c)
The switch shall be permanently mounted in a protected
area so that it cannot be operated outside the protected area except for
portable, mobile, or veterinary radiographic equipment.

(B)
In addition to the applicable quality assurance
requirements of Chapter 3701:1-66 of the Administrative Code, handlers of
radiographic equiment shall comply with the following:

(1)
The kilovoltage
peak (kVp) accuracy shall be within plus or minus ten per cent of the indicated
value.

(2)
The accuracy of the timing device shall be within plus
or minus ten per cent of the indicated setting. The timing device shall be
tested at a minimum of two settings within the operative range of fifty
milliseconds to one thousand milliseconds.

(a)
Of the kVp reproducibility for at least four
consecutive exposures shall not exceed 0.05;

(b)
Of the timing
device reproducibility for at least four consecutive exposures shall not exceed
0.05; and

(c)
Of radiation exposure reproducibility for at least
four consecutive exposures shall not exceed 0.05 for any specific combination
of selected technique factors.

(4)
For radiographic
equipment having independent selection of x-ray tube current (mA), the average
ratios of exposure to the indicated mA-seconds (mAs) product obtained at any
two consecutive tube current settings shall not differ by more than ten per
cent of their sum.

(5)
For radiographic equipment having a combined x-ray
tube current-exposure time product, or mAs selector, but not a separate tube
current, or mA selector, the average ratios of exposure to the indicated
milliampere-seconds product (milligray/mAs) values obtained at any two
consecutive mAs selector settings shall not differ by more than ten per cent of
their sum.

(6)
The average exposure ratio for paragraphs (B)(4) and
(B)(5) of this rule shall be expressed as follows:

|X1 - X2|
< 0.10 (X1
+X2 )

Where the value of
X1 and X2 are the average
milligray/mAs values obtained at each of the two consecutive tube mA or mAs
settings, or at two settings differing by no more than a factor of two where
the mA or mAs selector provides continuous selection.

(C)
In
addition to the applicable radiation safety rules in Chapter 3701:1-38 and
rules 3701:1-66-02 and
3701:1-66-04 of the
Administrative Code, the operator of radiographic equipment shall limit the
useful beam to the area of clinical interest, not to exceed the size of the
image receptor by more than two per cent of the source-to-image
distance.

(D)
Handlers of mobile or portable radiographic equipment
shall not be required to comply with the requirements of paragraph (I) of rule
3701:1-66-02 of the
Administrative Code, and shall comply with the following:

(a)
Used continuously for greater than one week in the
same location, such as a room or suite, shall have the x-ray control
permanently mounted in a protected area so that the operator is required to
remain in that protected area during the entire exposure; or

(b)
Used for less
than one week at the same location shall be provided with either a protective
barrier at least 6.5 feet high for operator protection during exposures, or
means shall be provided to allow the operator to be at least six feet from the
tube housing assembly during exposures and the operator shall wear a protective
apron of not less than 0.25 millimeter lead equivalent when making
exposures;

(2)
Radiation emitted from the x-ray tube when a capacitor
energy storage system is fully charged and the exposure switch, timer, or any
discharge mechanism is not activated shall not exceed an air kerma of 0.26
microgray in one minute at five centimeters from any accessible surface of the
diagnostic source assembly, with the beam-limiting device fully open;
and

(3)
A tube stand or other mechanical support shall be used
so that the x-ray tube housing assembly shall not be hand-held during
exposures.

(E)
Handlers of stationary veterinary radiographic
equipment shall not be required to comply with the requirements of paragraph
(I)(4) of rule
3701:1-66-02 of the
Administrative Code. However, stationary veterinary radiographic equipment
shall be provided with either a 6.5 foot high protective barrier for operator
protection during exposures, or shall be provided with means to allow the
operator to be at least six feet from the tube housing assembly during
exposures. If the operator or assistant is not behind the protective barrier, a
lead apron of not less than 0.25 millimeter lead equivalent shall be worn when
making exposures;

(F)
Handlers of mobile or portable veterinary radiographic
equipment shall not be required to comply with the requirements of paragraph
(I) of rule
3701:1-66-02 of the
Administrative Code. However , mobile or portable veterinary radiographic
equipment shall be provided with either a 6.5 foot high protective barrier for
operator protection during exposures, or shall be provided with means to allow
the operator to be at least six feet from the tube housing assembly during
exposures. If the operator or assistant is not behind the protective barrier, a
lead apron of not less than 0.25 millimeter lead equivalent shall be worn when
making exposures;

(G)
Handlers of certified veterinary radiation-generating
equipment specifically designed by the manufacturer to be hand-held during
radiographic exposures shall not be required to comply with the requirements of
paragraph (I) of rule
3701:1-66-02 of the
Administrative Code. The handler shall develop and implement safe operating
procedures as part of the quality assurance program specified in rule
3701:1-66-04 of the
Administrative Code, which shall address and document at least the
following:

(1)
Hand-held radiation-generating equipment shall be used for intraoral, extremity
or small animal purposes only;

(2)
Examination
specific source-to-image distances shall be developed and implemented to assure
the useful beam is limited to the area of clinical interest or no larger than
the image receptor;

(3)
Operators of the hand-held radiation-generating
equipment and individuals participating in the x-ray procedure shall be
protected from direct scatter radiation by protective aprons of not less than
0.25 millimeter lead equivalent material;

(4)
If the hand-held
radiation-generating equipment is designed with a back scatter shield, the
backscatter shield shall be in place during all radiographic
exposures;

(5)
Storage and security procedures shall be developed and
implemented to assure hand-held radiation-generating equipment is secured
against unauthorized use or removal when not under the control and constant
surveillance of the handler;

(6)
Hand-held
radiation generating equipment shall not be used in hallways or waiting rooms;
and

As used in this rule, "dental equipment" means
radiation-generating equipment used for dental radiography. In addition to
other applicable rules adopted pursuant to Chapter 3748. of the Revised Code
and Chapter 3701:1-66 of the Administrative Code, handlers of dental equipment
shall comply with the following:

(A)
Dental equipment for intraoral use shall meet the following equipment
standards:

(1)
A means shall be provided to
limit the source-to-skin distance (SSD) to not less than:

(2)
The x-ray field at the minimum SSD shall
be containable in a circle having a diameter of no more than seven centimeters
.

(3)
A means shall be
provided to terminate the exposure at a preset time interval, a preset product
of current and time, a preset number of pulses, or a preset radiation exposure
to the image receptor.

(4)
The
exposure control switch shall meet the following
requirements:

(b)
The operator
shall be able to terminate the exposure at any time during an exposure of
greater than one-half second. Except during panoramic radiography, termination
of the exposure shall cause automatic resetting of the timer to its initial
setting or to zero.

(c)
It shall not be possible to make an exposure when the
timer is set to "zero" or "off" position if either position is
provided.

(5)
The
kVp accuracy shall be within plus or minus ten per cent of the indicated
value.

(6)
For manual exposures,
the accuracy of the timing device shall be within plus or minus ten per cent of
the indicated setting. The timing device shall be tested at a minimum of two
settings within the operative range of fifty milliseconds to one thousand
milliseconds.

(7)
Visual indication
shall be provided whenever x-rays are produced. Certified equipment also shall
provide audible indication to the operator while x-rays are produced or on
termination of the exposure.

(8)
The coefficient of variation for reproducibility of kVp, timing, and radiation
exposure shall not exceed 0.05 for four consecutive exposures

(B)
In addition to other
structural shielding requirements in rule
3701:1-66-02 of the
Administrative Code, handlers of dental equipment shall comply with the
following:

(1)
Intraoral and panoral units
shall be provided with primary barriers at all areas struck by the useful beam.
Consideration may be given to the attenuation provided by the patient as a
result of direct interaction with the useful beam.

(2)
When intraoral or panoral units are in
adjacent patient occupied rooms or areas, protective barriers shall be provided
between the rooms or areas, unless safety procedures are documented and
implemented to require that no patients shall be present in the adjacent rooms
or areas while exposures are being made.

(3)
Intraoral and
panoral units shall be provided with a protective barrier for the operator or
shall be so arranged that the operator is located at a minimum distance of six
feet from the patient and out of the useful beam. The operator's position shall
be arranged so that the operator views the patient during the entire
exposure.

(4)
When the operator is behind a protective barrier, a
viewing system shall be provided large enough and so placed that the operator
can see the patient without having to leave the protected area during
exposure.

(C)
In
addition to the radiation safety requirements listed in rule
3701:1-66-02 of the
Administrative Code, handlers of dental equipment shall
not permit any individual to hold any part of the x-ray
tube housing, cone, or mechanical support of the x-ray tube during
exposure.

(D)
Handlers of dental equipment shall comply
with all applicable quality assurance requirements of rules
3701:1-66-02 and
3701:1-66-04 of the
Administrative Code.

(E)
Handlers
of dental panoral equipment shall comply with all requirements of paragraphs
(A) to (D) of this rule, except for paragraphs (A)(1) and (A)(2) of this rule,
and must comply with the following:

(1)
Dental
panoral x-ray machines shall be certified pursuant to 21 C.F.R. part 1020 (as
published in the April 1, 2012, Code of Federal Regulations).

(2)
The x-ray field shall be limited to the
dimensions of the slit in the image receptor holder or
limited to the dimensions of the active portion of the image
receptor.

(F)
Except for dental equipment used for panoral use, handlers of radiographic
equipment used for extraoral dental procedures shall comply with the
requirements of paragraphs (A) and (B) of rule
3701:1-66-05 of the
Administrative Code.

(G)
Fluoroscopy without image intensification shall
not be used for dental examinations. Handlers of image
intensified fluoroscopic equipment shall comply with the applicable
requirements of rule
3701:1-66-07 of the
Administrative Code and be included in the registrant's quality assurance
program as specified in rule
3701:1-66-04 of the
Administrative Code.

(H)
Handlers of dental cone-beam CT
radiation-generating equipment , shall comply with
the applicable requirements of rule
3701:1-66-10 of the
Administrative Code and be included in the registrant's quality assurance
program
as specified in rule
3701:1-66-04 of the
Administrative Code.

(I)
Handlers
of hand-held radiation-generating equipment used for dental procedures shall
meet the requirements of paragraphs (A), (B), and (D) of this rule, and shall
develop and implement safe operating procedures as part
of the quality assurance program specified in rule
3701:1-66-04 of the
Administrative Code, which shall address at least the following:

(2)
Operators of the hand-held
radiation-generating equipment shall wear a full lead apron of not less than
0.25 millimeter lead equivalent;

(3)
If the hand-held radiation-generating equipment is
designed with a back scatter shield, the
backscatter shield shall be in place during all
radiographic exposures;

(4)
Storage and security procedures shall be
developed and implemented to assure hand-held radiation-generating equipment is
secured against unauthorized use or removal when not under the control and
constant surveillance of the registrant;

(5)
Operator training as required in paragraph
(B)(5) of rule
3701:1-66-04 of the
Administrative Code, shall include documented specific instruction to the x-ray
operator regarding the prohibition on placing any part of their body into the
useful beam and ensuring there are no bystanders within
a radius of at least six feet from the patient being examined during
exposure.

(J)
Dental equipment with a nominal fixed kVp of less than fifty shall not be used
to make diagnostic dental radiographs of human beings.

(K)
Dental equipment used by veterinarians
shall comply with all requirements of this rule except paragraphs (A)(1), (E),
and (J) of this rule. Additionally, the useful beam shall be limited to the
area of clinical interest.

(L)
Extraoral dental equipment used by veterinarians shall follow the requirements
of paragraph (F) of rule
3701:1-66-05 of the
Administrative Code.

For the purposes of this rule, "fluoroscopic equipment" means a
type of radiation-generating equipment that is used for real-time imaging of
internal structures for medical purpose. In addition to other applicable rules
adopted pursuant to Chapter 3748. of the Revised Code, handlers of fluoroscopic
equipment shall comply with the following:

(1)
Unless the United
States food and drug administration (FDA) has granted a variance for the
specific fluoroscopic equipment, the source-to-skin distance (SSD) shall not be
less than:

(a)
Thirty-eight centimeters on
stationary fluoroscopic equipment unless a particular
procedure application prohibits that distance, in which case the SSD shall not
be less than twenty centimeters.

(b)
Thirty centimeters
on mobile fluoroscopic equipment unless a particular procedure prohibits that
distance, in which case it shall not be less than twenty centimeters .

(c)
Nineteen centimeters for c-arm type fluoroscopic
equipment having a maximum source-to-image distance (SID) less than forty-five
centimeters unless a particular procedure prohibits that distance, in which
case it shall not be less than ten centimeters. Such systems shall be used for
extremity or dental purposes only.

(2)
For
c-arm fluoroscopic equipment equipped with a removable spacer cone, the spacer
cone shall be attached to the x-ray source during use at all times unless it
interferes with the clinical procedure.

(3)
The fluoroscopic imaging assembly shall be
provided with a primary protective barrier which intercepts the entire cross
-section of the useful beam at any SID and shall
prevent further exposures when the primary barrier is not in the path of the
entire x-ray beam.

(4)
All fluoroscopic
equipment shall provide intensified imaging. As used in this rule "intensified
imaging" will include the use of digital image receptors.

(5)
Fluoroscopic equipment shall meet the following
field limitation specifications:

(a)
For
fluoroscopic equipment manufactured before June 10, 2006, the following
applies:

(i)
Neither the length nor the width
of the x-ray field in the plane of the image receptor shall exceed that of the
visible area of the image receptor by more than three per cent of the SID. The
sum of the excess length and the excess width shall be no greater than four per
cent of the SID.

(ii)
For
rectangular x-ray fields used with circular image receptors, the error in
alignment shall be determined along the length and width dimensions of the
x-ray field which pass through the center of the visible area of the image
receptor.

(b)
For
fluoroscopic equipment with a circular image receptor manufactured on or after
June 10, 2006, the maximum area of the x-ray field in the plane of the circular
image receptor shall conform with one of the following requirements. When any
linear dimension of the visible area of the image receptor measured through the
center of the visible area is:

(i)
Less than
or equal to thirty-four centimeters in any direction, at least eighty per cent
of the area of the x-ray field shall overlap the visible area of the image
receptor ;
or

(ii)
Greater than thirty-four
centimeters in any direction, the x-ray field measured along the direction of
greatest misalignment with the visible area of the image receptor shall not
extend beyond the edge of the visible area of the image receptor by more than
two centimeters.

(c)
For
fluoroscopic equipment with a rectangular image receptor manufactured on or
after June 10, 2006, the following applies:

(i)
Neither the length nor the width of the
x-ray field in the plane of the image receptor shall exceed that of the visible
area of the image receptor by more than three per cent of the SID. The sum of
the excess length and the excess width shall be no greater than four per cent
of the SID; and

(ii)
The error in
alignment shall be determined along the length and width dimensions of the
x-ray field which pass through the center of the visible area of the image
receptor.

(d)
If the
fluoroscopic x-ray field size is adjusted automatically as the SID or image
receptor size is changed, a capability may be provided for overriding the
automatic adjustment in case of system failure. If it is so provided, a signal
visible at the operator's position shall indicate whenever the
automatic field adjustment is overridden. Each such system failure override
switch shall be clearly labeled as follows:

"For X-ray Field Limitation System Failure"

(e)
Beam-limiting devices shall be provided
with a means for stepless adjustment of the x-ray field; and

(f)
Stepless adjustment shall, at the
greatest SID, provide continuous field sizes from the maximum obtainable to a
field size of five centimeters by five centimeters or less.

(a)
A means
shall be provided to preset the cumulative on-time timer of the fluoroscopic
tube. The maximum cumulative time of the timer shall not exceed five minutes
without resetting; and

(b)
The
timer shall terminate the exposure or emit a signal audible to the
operator when the exposure time reaches a maximum of
five minutes. The signal shall continue to sound while x-rays are produced
until the timer is reset.

(c)
For
x-ray controls manufactured on or after June 10, 2006, there shall be provided
for each fluoroscopic tube:

(i)
A display of
the fluoroscopic irradiation time at the operator's working position. This display shall
function independently of the audible signal described in paragraph (A)( 6)(c)(ii) of this
rule. The following requirements apply:

(a)
When the x-ray tube is activated, the fluoroscopic irradiation time in minutes
and tenths of minutes shall be continuously displayed and updated at least once
every six seconds.

(b)
The
fluoroscopic irradiation time shall also be displayed within six seconds of
termination of an exposure and remain displayed until reset.

(c)
Means shall be provided to reset the
display to zero prior to the beginning of a new examination or
procedure.

(ii)
A signal
audible to the operator shall sound for each passage of five minutes
of fluoroscopic irradiation time during an examination or procedure. The signal
shall sound until manually reset or, if automatically reset, for at least two
seconds.

(7)
X-ray production in the fluoroscopic mode shall
be controlled by a device which requires continuous pressure by the
operator for the entire time of any exposure. When
recording serial fluoroscopic images, the operator
shall be able to terminate the x-ray exposure at any time, but means may be
provided to permit completion of any single exposure of the series in
progress.

(a)
Fluoroscopic equipment provided with only
automatic exposure rate control, or provided with both automatic exposure rate
control and manual mode capabilities, shall not exceed an air kerma rate of
eighty-eight milligray per minute (ten roentgens per minute exposure rate) in
either mode at any combination of tube potential and current, at the point
where the center of the useful beam enters the patient;

(b)
Fluoroscopic equipment provided with only
manual mode capabilities shall not exceed an air kerma rate of forty-four
milligray per minute (five roentgens per minute exposure rate) at any
combination of tube potential and current, at the point where the center of the
useful beam enters the patient; and

(c)
For fluoroscopic equipment that is
provided with high-level control, and the high-level control is activated, the
air kerma rate shall not exceed one hundred seventy-six milligray per minute
(twenty roentgens per minute exposure rate) at any combination of tube
potential and current, at the point where the center of the useful beam enters
the patient;

(i)
For all fluoroscopy equipment
that is provided with high-level control, special means of activation of high
level control, such as manual pressure applied continuously by the
operator, shall be required to avoid accidental use;
and

(ii)
A continuous signal
audible to the operator shall indicate that high level control
is being employed.

(9)
During fluoroscopy and cinefluorography
the x-ray tube potential and current shall be continuously indicated.

(10)
For undertable fluoroscopic equipment, a
shielding device of at least 0.25 millimeter lead equivalent shall cover the
bucky-slot.

(11)
For undertable
fluoroscopic equipment, protective drapes, or other devices, at least 0.25
millimeter lead equivalent shall be provided between the patient and the
individual operating the fluoroscopic equipment to intercept scattered
radiation which would otherwise reach the fluoroscopist and others near the
x-ray unit, except when such drapes or other devices would compromise the
sterile field. Such devices shall not substitute for wearing required
protective apparel.

(12)
Radiography using the fluoroscopic imaging assembly
shall meet the following specifications:

(a)
A
means shall be provided between the source and the patient which will
automatically limit the x-ray field at the time the exposure is initiated to no
more than the portion of the image receptor selected by the
operator. If the x-ray field size is less than
the size of the selected portion of the image receptor, the field size shall
not open automatically to the size of the selected portion of the image
receptor unless the operator has selected such a mode of
operation;

(b)
Neither the length
nor the width of the x-ray field in the plane of the image receptor shall
differ from the corresponding dimensions of the selected portion of the image
receptor by more than three per cent of the SID when adjusted for full coverage
of the selected portion of the image selector;

(c)
The center of the x-ray field in the
plane of the image receptor shall be aligned with the center of the selected
portion of the image receptor to within two per cent of the SID;
and

(d)
Means shall be provided to reduce the
x-ray field size in the plane of the image receptor to a size smaller than the
selected portion of the image receptor. The minimum field size at the greatest
SID shall not exceed five centimeters by five centimeters .

(13)
Fluoroscopic equipment manufactured on or after
June 10, 2006, shall display at the operator's working position the air kerma rate
(AKR) and cumulative air kerma in accordance with
the following requirements:

(a)
When the x-ray
tube is activated and the number of images produced per unit time is greater
than six images per second, the AKR in milligrays per minute shall be
continuously displayed and updated at least once every second.

(b)
The cumulative
air kerma in units of milligrays shall be displayed either within five seconds
of termination of an exposure or displayed continuously and updated at least
once every five seconds.

(c)
The display of the AKR shall be clearly
distinguishable from the display of the cumulative air kerma.

(d)
The AKR and
cumulative air kerma shall represent the value for conditions of free-in-air
irradiation at one of the following reference locations specified according to
the type of fluoroscope.

(i)
For fluoroscopes
with x-ray source below the x-ray table, x-ray source above the table, or of
lateral type, the reference location shall be the respective locations
specified in paragraph (C)(6)(a), (C)(6)(b) or (C)(6)(d) of this
rule.

(ii)
For C-arm fluoroscopes, the reference location shall
be fifteen centimeters from the isocenter toward the x-ray source along the
beam axis. Alternatively, the reference location shall be at a point specified
by the manufacturer to represent the location of the intersection of the x-ray
beam with the patient's skin.

(e)
Means shall be
provided to reset to zero the display of cumulative air kerma prior to the
commencement of a new examination or procedure.

(f)
The displayed
AKR and cumulative air kerma shall not deviate from the actual values by more
than plus or minus thirty-five per cent.

(B)
In addition to other applicable radiation safety
rules adopted pursuant to Chapter 3748. of the Revised Code, handlers of
fluoroscopic radiation-generating equipment shall comply with the following:

(1)
Any individual who is in the room during
the fluoroscopic procedure shall be adequately protected by standing behind a
whole body protective barrier or shall be required to wear a protective lead
apron of not less than 0.25 millimeter lead equivalent.

(2)
Protective lead or lead equivalent gloves
shall be used by individuals who are required to have their hands in or near
the useful beam.

(3)
In accordance
with Chapter 3701-72 of the Administrative Code, individuals who perform
fluoroscopic procedures on human beings shall hold a radiographer license or
shall be a licensed practitioner, except for those individuals
identified in paragraph ( D) of rule
3701-72-04 of the Administrative
Code who are limited to performing only the radiologic tasks related to cardiac
catheterization procedures as specified in paragraph
(D) of rule
3701-72-04 of the Administrative
Code. Personnel working for veterinarians that use radiation generating
equipment are not required to comply with this paragraph.

(4)
Handlers of
fluoroscopic equipment used for interventional or cardiac procedures or on
pediatric or pregnant patients shall maintain a record of:

(a)
Cumulative air kerma or dose area product
used for each examination, if the display of either is available on the
fluoroscopic equipment; or

(b)
The
following items if the cumulative air kerma or dose area product is not
displayed on the fluoroscopic equipment:

(C)
In addition to other applicable quality
assurance requirements of Chapter 3701:1-66 of the Administrative Code,
handlers of fluoroscopic equipment shall comply with the following:

(1)
Handlers shall designate and utilize a
radiation expert who shall develop in writing and perform fluoroscopic image
quality evaluations appropriate for the fluoroscopic equipment including
written procedures to include time intervals and system conditions for the
evaluation of image quality.

(2)
On
new installations or reinstallations of existing
equipment prior to patient exposure, handlers shall utilize a radiation
expert to perform the following:

(a)
Radiographic device tests to determine compliance with
allowable limits as specified in paragraph (A)(12) of this rule;

(b)
Fluoroscopic image quality evaluations as
specified in paragraph ( C)(1) of this rule; and

(c)
Air kerma rate tests as specified in
paragraph (C)(6) of this rule.

(3)
After initial evaluations of fluoroscopic
equipment have been performed, the test and evaluations in paragraph ( C)(2) of this rule
shall be performed by a radiation expert annually within periods not to exceed
fourteen months.

(4)
After
repair or replacement of any component of the fluoroscopic equipment which may
alter the radiation output or image quality,
prior to patient
use , a radiation
expert shall perform and document measurements of air kerma rates as specified
in paragraph (C)(6) of this rule and image quality as specified in paragraph
(C)(1) of this rule unless in the documented determination of a radiation
expert, the repair or replacement will not cause a significant change in
radiation output or significant degradation of image quality as specified in
the quality assurance program.

(a)
The
radiation expert
may designate qualified individuals to perform
and document the measurements
specified in
paragraphs (C)(6) and (C)(1) of this rule ;

(b)
The radiation expert shall
provide the
criteria for qualifying these designees
in the quality assurance program; and

(c)
The radiation expert's approval of the
test results shall be documented.

(5)
The results of all
tests performed in accordance with paragraphs ( C)(2) to ( C)(4) of this rule
shall:

(d)
Be maintained by
the IRRP between inspections for review by the department.

(6)
Compliance with
air kerma rate allowable limits in paragraph (A)(8) of this rule shall be
determined as follows:

(a)
If the source is below the x-ray table, the air kerma
rate shall be measured at one centimeter above the tabletop or
cradle.

(b)
If the source is above the x-ray table, the air kerma
rate shall be measured at thirty centimeters above the tabletop with the end of
the beam limiting device or spacer positioned as closely as possible to the
point of measurement.

(c)
For c-arm type fluoroscopic equipment, the air kerma
rate shall be measured at thirty centimeters from the input surface of the
image receptor with the source positioned at any SID.

(d)
For fixed SID
lateral fluoroscopes attached to the x-ray table, the maximum air kerma rate
shall be measured at a point fifteen centimeters from the centerline of the
x-ray table and in the direction of the x-ray source with the end of the
beam-limiting device or spacer positioned as closely as possible to the point
of measurement. If the table top is moveable, it shall be positioned as closely
as possible to the lateral x-ray source, with the end of the beam-limiting
device or spacer no closer than fifteen centimeters to the centerline of the
table.

(e)
For c-arm type fluoroscopic equipment having a SID
less than forty-five centimeters, the air kerma rate shall be determined at the
minimum SSD.

(f)
The maximum air kerma rate shall be determined with
the kVp, mA and/or other selectable parameters adjusted to those settings which
give the maximum air kerma rate. X-ray systems that incorporate automatic
exposure control shall have sufficient attenuative material placed in the
useful beam to produce the maximum exposure rate of the system.

(D)
Handlers of mobile
fluoroscopic equipment shall not be required to comply with the requirements of
paragraphs (A)(10), and
(A)(11)
of this rule and
paragraph (I) of rule
3701:1-66-02 of the
Administrative Code.

(E)
Handlers of c-arm fluoroscopic equipment having
a maximum SID less than forty-five centimeters shall not be required to comply
with the requirements of paragraphs (A)(5)(e),
(A)(5)(f), (A)(10), (A)(11),
and (A)(12)
of this rule and
paragraph (I) of rule
3701:1-66-02 of the
Administrative Code. In addition, if a radiation
expert has specified in the registrant's quality assurance program that an
individual is unlikely to receive a total effective dose equivalent of greater
than two millirem in any one hour or one hundred millirem in a year, the
handler shall not be required to comply with the requirements of paragraph
(B)(1) of this rule.

(F)
All individuals operating fluoroscopic
equipment, and individuals likely to receive an annual effective dose
equivalent in excess of one millisievert (one hundred millirem) from
participating in fluoroscopic procedures, shall receive at least two hours of
radiation protection training specific to fluoroscopy in addition to the
training required by rule
3701:1-38-10 of the
Administrative Code prior to performing or participating in fluoroscopic
procedures. Additionally, each individual shall receive one hour of re-training
whenever the individual receives in excess of thirty per cent of the allowable
occupational dose measured over one calendar year.

(G)
The training required by paragraph ( F) of this rule
shall be provided by an Ohio registrant, approved by the registrant's
designated radiation expert, and be specific to the type of fluoroscopic
equipment used. Documentation of receiving the
training required by paragraph ( F) of this rule shall be retained by the registrant
and be available for review upon inspection. At a minimum, training topics
shall include, but not be limited to:

(1)
Principles and operation of the fluoroscopic equipment to be used;

(2)
Fluoroscopic outputs including high-level
control options as applicable;

This rule provides standards for radiation-generating equipment
used for screening and diagnostic mammography, and mammography equipment used
for invasive localization and stereotactically-guided breast biopsy purposes,
except as provided by paragraphs (E) and (F)
of this rule. In addition to Chapters 3701:1-38 and 3701:1-66 of the
Administrative Code, a handler of mammography radiation-generating equipment
that uses either stationary or mobile installations, shall comply with all
applicable standards in 21 C.F.R. 1020 (as published in the April 1,
2012,
Code of Federal Regulations) and the following:

(A)
In addition to meeting the applicable
equipment standards in rule
3701:1-66-02 of the
Administrative Code, a facility performing screening
or diagnostic mammography shall have a valid certificate issued by the U.S.
department of health and human services, pursuant to the Mammography Quality
Standards Reauthorization Act of 1998,
Public Law
105-248, and 21 C.F.R. Part 900.

(B)
A handler of all types of mammography
radiation-generating equipment shall comply with the shielding requirements in
paragraphs (I)(2) to
(I)(4) of rule
3701:1-66-02 of the
Administrative Code.

(C)
In
addition to applicable radiation safety requirements in rules adopted pursuant
to Chapter 3748. of the Revised Code and rule
3701:1-66-02 of the
Administrative Code, a handler of all types of screening and diagnostic
mammography radiation-generating equipment shall comply with the following:

(1)
When a film/screen mammography system is
used, clinical films shall be processed as soon as possible, but not to exceed
twenty-four hours from the time the first clinical image is taken. Facilities
utilizing batch processing shall:

(a)
Use a
container to transport clinical films that will protect the film from exposure
to light, excessive heat and radiation; and

(b)
Maintain a log to include date and
identification of each patient, time of first exposure of each batch, and date
and time of each batch processing.

(2)
An individual, other than a licensed
practitioner, operating any type of mammography equipment on
human beings shall possess an Ohio radiographer license in accordance
with rules in Chapter 3701-72 of the Administrative Code and meet
at least one of the following
initial qualifications:

(a)
Documented evidence of having completed
sixteen hours of structured education in mammography
which was university-awarded or approved by a
recognized continuing education evaluation mechanism as accepted by the
"American
Registry of Radiologic Technologists"; or

(b)
Proof of advanced certification in
mammography issued to the operator by the "American Registry of Radiologic
Technology."

(D)
In addition to all applicable quality
assurance requirements in rules
3701:1-66-02 and
3701:1-66-04 of the
Administrative Code, the facility shall maintain phantom
and quality control images for three months.

(E)
Radiation-generating equipment designed for mammography but used exclusively for
radiography of tissue from a biopsy,
shall be exempt from paragraphs (A) to (D) of this rule, and shall comply with
the requirements set forth in paragraphs (A), (F), (H)(1), (I)(2),
(I)(3) and (J) of rule
3701:1-66-02 of the
Administrative Code.

(F)
Radiation-generating equipment used for radiography of
tissue from a biopsy and equipped with an x-ray tube enclosure designed to
exclude personnel from its interior during x-ray generation shall be exempt
from paragraphs (A) to (E) of this rule, and shall comply with the requirements
set forth in paragraph (H)(2) of rule
3701:1-68-03 of the
Administrative Code.

(G)
Quality control testing by a medical physicist shall
be conducted on mammography radiation-generating equipment
used for invasive localization or having
stereotactically-guided breast biopsy capability. Quality control
testing for stereotactically-guided breast biopsy equipment shall follow
the "American College of Radiology (ACR) Practice
Guideline for the Performance of Stereotactically Guided Breast Interventional
Procedures" (as revised in 2009). This document is available from the
"American College of Radiology, 1891 Preston White Drive, Reston, Virginia
20191, telephone (703) 648-8900."

(1)
The medical physicist shall meet the requirements of the
aforementioned ACR guideline; and

(2)
The medical
physicist shall document and verify that the facility is taking proper
corrective actions when results of the quality control tests indicate the
need.

As used in this rule, "computed
tomography (CT) radiation-generating equipment" means CT units as defined in
paragraph (B)(12) of rule
3701:1-66-01 of the
Administrative Code and used for medical purpose, except for fluoroscopy units
with CT capability, CT units used exclusively for radiotherapy simulation and
CT units integrated with linear accelerators. In addition to other applicable
rules adopted pursuant to Chapter 3748. of the Revised Code and Chapter
3701:1-66 of the Administrative Code, handlers of CT radiation-generating
equipment that includes either mobile or stationary installations shall comply
with the following:

(A)
CT radiation-generating equipment shall be maintained
to meet the following equipment standards:

(1)
The operator
shall be able to terminate x-ray exposure at any time during a scan, or series
of scans under CT radiation-generating equipment control of greater than 0.5
second duration.

(2)
In the case of premature termination of the x-ray
exposure by the operator, the CT radiation-generating equipment shall require
the operator to reset CT conditions of operation prior to the initiation of
another scan.

(4)
If the x-ray
production period is less than 0.5 second, the indication of x-ray production
shall be actuated for at least 0.5 second. Visual indicators at or near the
gantry shall be discernible from any point external to the patient opening
where insertion of any part of the human body into the primary beam is
possible.

(5)
Each emergency button or switch shall be clearly
labeled as to its function.

(6)
The CT
radiation-generating equipment shall be designed such that the CT conditions of
operation are indicated prior to the initiation of a scan or a scan
sequence.

(7)
The indicated table increment shall not deviate from
the actual table increment by more than one millimeter.

(8)
Means shall be
provided to permit visual determination of the location of the tomographic
plane or a reference plane. A reference plane may be offset from the location
of the tomographic plane(s).

(9)
If a device
using a light source is used to satisfy paragraph (A)(8) of this rule, the
light source shall provide illumination levels sufficient to permit visual
determination of the location of the tomographic plane or reference plane under
ambient light conditions of up to five hundred lux.

(10)
The total error
in the indicated location of the tomographic plane or reference plane shall not
exceed five millimeters.

(11)
Mobile CT radiation-generating equipment permanently
mounted on a base with wheels or castors for moving while completely assembled
shall be provided with curtains of not less than 0.25 millimeter lead
equivalent that completely surrounds the gantry bore during
exposures.

(B)
In addition to paragraph (H) of rule
3701:1-66-02 of the
Administrative Code, handlers of CT radiation-generating equipment shall meet
the following radiation safety requirements:

(1)
Techniques shall
be provided in the vicinity of the control panel or on a pre-programmed menu,
based on patient age, weight, body mass index, or patient dimensions, as
appropriate, that specifies for each routine examination the CT conditions of
operation, including techniques specific to pediatric patient examinations, if
applicable.

(3)
If the results of the quality control tests, the image
quality evaluations, or the radiation dose measurements exceed a tolerance
limit established by a radiation expert, use of the CT radiation-generating
equipment on patients shall be limited to those uses permitted by written
instruction of a radiation expert.

(4)
Operators of CT
radiation-generating equipment used on humans shall possess an Ohio radiologic
license in accordance with Chapter 3701-72 of the Administrative Code or hold
an appropriate license or certificate in accordance with Chapter 4715. of the
Revised Code for dental imaging.

(C)
In addition to
other applicable quality assurance requirements in rule
3701:1-66-04 of the
Administrative Code, handlers of CT radiation-generating equipment shall comply
with the following quality assurance requirements:

(1)
The registrant
shall designate and utilize a radiation expert who shall:

(ii)
After repair or replacement of any component of the CT
equipment which may alter the radiation output or image quality, prior to
patient use, a radiation expert shall perform and document measurements of
radiation output, using a method specified by a radiation expert in the quality
assurance program, and image quality as specified in paragraph (C)(1)(c) of
this rule unless in the documented determination of a radiation expert, the
repair or replacement will not cause a significant change in radiation output
or significant degradation of image quality as defined in the quality assurance
program according to paragraph (C)(1)(c) of this rule.

(A)
The radiation expert may designate qualified individuals to
perform and document the measurements specified in paragraph (C)(1)(a)(ii) of
this rule;

(B)
The criteria for
qualifying the designees specified in paragraph (C)(1)(a)(ii)(a) of this rule
shall be specified by a radiation expert in the quality assurance program;
and

(C)
The radiation expert's
approval of the test results shall be documented.

(c)
Develop written procedures to include system
conditions and tolerance limits for the evaluation of image quality. The
procedures shall incorporate the use of a CT phantom which has the capability
of providing an indication of CT number accuracy for at least three materials,
noise, image thickness, alignment light accuracy, and the resolution capability
of the system for low and high contrast objects.

(d)
Perform
evaluations of image quality according to the written procedures upon
installation and prior to scanning patients and at least annually, not to
exceed a fourteen month period, thereafter.

(e)
Approve the
quality control program conducted by the CT technologist including the image
quality evaluations appropriate for the system and allowable variations for the
indicated parameters.

(2)
Written records
of all image quality evaluations and radiation dose measurements shall be
maintained between inspections for review by the department's
inspector.

(3)
The images for quality shall be retained until a new
image quality evaluation is performed as follows:

(a)
Photographic
copies of the images obtained from the image display device; or

(b)
Images stored in
digital form on a storage medium compatible with the CT x-ray
system.

(4)
In consultation with a radiation expert, develop and
implement a written program for radiation dose optimization and scan protocol
review. The protocol review must include perfusion studies, if performed. The
written program shall be audited by a radiation expert on an annual basis, not
to exceed a fourteen month period.

(5)
Radiation dose
measurements shall be performed using clinical protocols representative of the
utlization of the CT unit. If protocols are estimated, measurements must be
based on a sample of actual patient data. The specific CT conditions of
operation shall be documented for each protocol;

(b)
Radiation dose measurements shall be performed using a
CT dosimetry phantom that meets the following specifications and conditions of
use:

(i)
The
CT dosimetry phantom shall be a right circular cylinder of a material having
approximate tissue equivalence of one gram per cubic centimeter. The phantom
shall be at least fourteen centimeters in length and shall have diameters of
thirty-two centimeters for measuring radiation dose from the adult abdomen scan
protocol and sixteen centimeters for measuring radiation dose from the head and
pediatric abdomen scan protocols;

(ii)
The CT
dosimetry phantom shall provide a means for the placement of a dosimeter along
the axis of rotation and along a line parallel to the axis of rotation on the
outer surface or within one centimeter from the outer surface and within the
phantom. Means for the placement of dosimeters or alignment devices at other
locations may be provided;

(iii)
Any effects on
the doses measured due to the removal of phantom material to accommodate
dosimeters shall be accounted for through appropriate corrections to the
reported data or included in the statement of maximum deviation for the values
obtained using the phantom; and

(iv)
All dose
measurements shall be performed with the CT dosimetry phantom placed on the
patient couch or support device without additional attenuation materials
present; and

(c)
Radiation dose measurements shall be performed with a
calibrated dosimetry system. The calibration of such system shall be traceable
to a national standard, or cross-calibrated with a dosimetry system whose
calibration is traceable to a national standard. Records of these calibrations
shall be readily available for review upon inspection. The dosimetry system
shall have been calibrated within the preceding two years.

(d)
Requirements of
paragraphs (C)(5)(a) and (C)(5)(b) of this rule may be satisfied by an
alternative nationally-recognized standard for CT dosimetry. If an alternate
dosimetry method is used, a radiation expert shall document the procedures in
the written quality assurance program.

(1)
Under the guidance of a radiation expert, handlers of
CBCT units shall develop and implement a written quality control testing
program to include test procedures, test frequencies, and tolerance
limits.

(2)
The written quality control program must include an
annual testing component to be performed by a radiation expert. This annual
testing component must be performed upon installation of new CBCT units and
annually thereafter, not to exceed fourteen months.

(3)
The annual tests
to be performed by a radiation expert must include an assessment of radiation
dose and an evaluation of image quality.

(4)
Records of all
quality control tests shall be documented and retained between
inspections.

(5)
CBCT scanners are exempt from paragraphs (B)(2) and
(C)(5) of this rule.

(6)
SPECT/CT and PET/CT units used exclusively for hybrid
imaging shall be in compliance with paragraph (B)(2) of this rule if protocols
used to scan the head satisfy the limits of paragraph (B)(2)(a) of this rule
and protocols used to scan the abdomen satisfy the limits of paragraph
(B)(2)(b) of this rule.

(E)
Micro-CT units
equipped with an x-ray tube enclosure designed to exclude personnel from its
interior during x-ray generation shall be exempt from paragraphs (A) to (D) of
this rule, and shall comply with the requirements set forth in paragraph (H)(2)
of rule
3701:1-68-03 of the
Administrative Code.

(F)
Mobile CT radiation-generating equipment permanently
mounted on a base with wheels or castors for moving while completely assembled
and not used in one place are exempt from paragraphs (I)(4) and (I)(5) of rule
3701:1-66-02 of the
Administrative Code.

For the purposes of this rule, "bone densitometry equipment"
means radiation-generating equipment intended for the medical purpose of
quantifying bone density and mineral content by x-ray measurements through the
bone and adjacent tissues. In addition to the applicable rules in Chapters
3701:1-38 and 3701:1-66 of the Administrative Code, handlers of bone
densitometry equipment shall comply with the following:

(A)
Handlers of bone densitometry equipment
shall assure that the equipment is certified by the manufacturer in accordance
with the requirements of 21
C.F.R. 1010.2 , as published in the April 1,
2012,
Code of Federal Regulations, and maintained in accordance with the
manufacturer's specifications.

(B)
In addition to other applicable radiation safety requirements in Chapters
3701:1-38 and 3701:1-66 of the Administrative Code, handlers of bone
densitometry equipment shall comply with the following:

(1)
The operator shall be positioned at least
one meter ( 3.3 feet) from the primary beam or behind a protective barrier
containing a minimum of 0.25 millimeter of lead equivalent materials.

(2)
Operators of bone densitometry equipment
shall possess an Ohio radiologic license in accordance with rules in Chapter
3701-72 of the Administrative Code.

(C)
In addition to other applicable quality
assurance requirements in rules
3701:1-66-02 and
3701:1-66-04 of the
Administrative Code, handlers of bone densitometry equipment shall comply with
the following:

(1)
The quality assurance
program shall include quality control test records which shall be maintained
between inspections and shall include the following:

(a)
A list of the tests to be performed as
specified by the manufacturer;

(2)
"Interlock"
means a device preventing the start or continued operation of equipment that
could cause a radiation hazard.

(3)
"Mode of
operation" means a selectable set of technique factors or machine settings that
is pre-determined by the manufacturer for a specific purpose.

(4)
"Scan" means the
operation necessary to produce one image (e.g., front view) from one radiation
source. One radiation source simultaneously producing multiple images also
constitutes one scan. Two sources simultaneously producing two images
constitute two scans. In some cases several scans may be required for a single
screening of the subject.

(5)
"Screening" means the sum of radiation exposures or
scans necessary to image objects concealed on all sides of the body as intended
by the system design under normal conditions:

(a)
For backscatter
systems a screening typically consists of four scans, one from each
side.

(b)
For transmission systems a screening typically
consists of one scan.

(c)
For portal systems a screening consists of a complete
pass through the inspection zone.

(6)
"Security
screening system" means radiation-generating equipment used for the sole
purpose of screening an individual who is in custody of a law enforcement
agency to identify contraband items that would present a security threat within
a secured facility perimeter.

(4)
Access panels to x-ray source and detector shall be
provided with at least one safety interlock.

(5)
Operational
safety interlocks must terminate the x-ray exposure in the event of any system
problem that could result in abnormal or unintended radiation
emission.

(6)
Following any premature termination, the security
screening system must prohibit resumption of x-ray generation until the normal
control sequence is reset for a new scan.

(7)
Equipment
designed to control the exposure output using multiple modes of operation shall
indicate the selected mode prior to each scan.

(8)
Technique
factors may not be adjustable and shall be preset by the manufacturer for each
mode of operation.

(9)
A means shall be provided to terminate the exposure at
a preset time interval or exposure.

(10)
When the x-ray
tube is operated at its maximum rated tube current for the maximum kilovoltage,
the leakage dose shall not be greater than 2.5 microsievert ( 0.25 millirem) in
any one hour at any point thirty centimeters from any external
surface.

(11)
The primary x-ray beam shall be attenuated by at least
one millimeter of aluminum- equivalent total filtration.

(C)
Handlers of security screening systems shall comply with the following
administrative and radiation safety requirements:

(1)
No individual
shall be exposed to the useful beam unless authorized by a law enforcement
agency for security benefit. No individual shall be exposed to the useful beam
for demonstration or frivolous purposes.

(2)
The individual
responsible for radiation protection shall ensure that all operators are
trained in the safe operation of the security screening
systems.

(3)
Any radiation-generating equipment that does not meet
the provisions set forth in this rule shall not be used to irradiate
individuals unless the director determines that the continued use will not pose
a radiation risk and arrangements have been made to promptly correct the
deficiency.

(5)
Radiation-generating equipment shall bear a warning label on the control panel
or by the exposure switch which cautions individuals that radiation is produced
when it is energized.

(6)
All position locking, holding, and centering devices
on radiation-generating equipment components shall function as designed by the
manufacturer.

(D)
Handlers of security screening systems shall comply
with the requirements of rule
3701:1-66-04 of the
Administrative Code, except for paragraphs (B)(8), (B)(15), (C) and (D)(5). In
addition, the written quality assurance program shall include the
following:

(1)
Policy prohibiting the frivolous use of security screening systems where no
security benefit is to be derived.

(2)
Policy requiring
individuals undergoing screening to be positioned facing away from the source
of radiation when using transmission security screening
systems.

(5)
Policy that operator training must follow the topics
listed in the "Personnel Training" section of the American National Standards
Institute publication "ANSI/HPS N 43.17 -2009 Radiation Safety for Personnel
Security Screening Systems Using X-Ray or Gamma Radiation."

(6)
For general-use
full-body security screening systems capable of delivering a maximum effective
dose less than or equal to 0.1 microsievert (ten microrem) per scan: policies
and records to show that administrative controls are applied to limit the
number of screenings received by any individual such that the reference
effective dose shall not exceed:

(b)
Two hundred fifty microsievert (twenty five millirem)
over any twelve month period.

(7)
For limited-use
full-body security screening systems capable of delivering a maximum effective
dose greater than 0.1 microsievert (ten microrem) per scan: policies and
records to show that administrative controls are applied to limit the number of
screenings received by any individual such that the reference effective dose
shall not exceed:

(b)
Two hundred fifty microsievert (twenty five millirem)
over any twelve month period.

(8)
For general-use
partial-body security imaging systems capable of delivering a maximum effective
dose less than or equal to 0.1 microsievert (ten microrem) per scan: policies
and records to show that administrative controls will be applied to limit the
number of screenings received by any individual, such that:

(a)
The ADAP shall
not exceed 0.03 microsievert per square meter (three microrem per square meter)
per scan; and

(b)
The total number of scans received at the facility in
a twelve month period does not exceed N, where N = seventy five microsievert
per square meter per ADAP (seven thousand five hundred microrem per square
meter per ADAP).

(9)
For limited-use
partial-body security imaging systems capable of delivering a maximum effective
dose greater than 0.1 microsievert (ten microrem) per scan: policies and
records to show that administrative controls will be applied to limit the
number of screenings received by any individual, such that:

(a)
The ADAP shall
not exceed three microsievert per square meter (three hundred microrem per
square meter) per scan; and

(b)
The total number
of scans received at the facility in a twelve month period does not exceed N,
where N = seventy five microsievert per square meter per ADAP (seven thousand
five hundred microrem per square meter per ADAP).

(1)
A clearly marked
restricted area shall be established. The dose outside of the restricted area
may not exceed twenty microseivert (two millirem) in any one
hour.

(2)
A means shall be provided for the operator responsible
for initiating the scan to maintain a full visual surveillance of the screening
and restricted area.

(3)
Engineering or administrative controls shall be
provided to ensure that individuals do not reenter the scanning area from the
exit while x-rays are being produced.

(F)
Reference
effective dose limits as specified in paragraphs (D)(6) and (D)(7) of this rule
and ADAP as specified in paragraphs (D)(8) and (D)(9) of this rule shall be
determined using the American National Standards Institute publication
"ANSI/HPS N 43.17 -2009 Radiation Safety for Personnel Security Screening
Systems Using X-Ray or Gamma Radiation" by a health physicist or radiation
expert or qualified individual designated by a radiation expert:

(3)
After any
maintenance or change that may affect the reference effective dose or
ADAP.

(G)
Screening systems capable of delivering an effective
dose greater than ten microsievert (one millirem) per scan shall not be used
for non-medical screening of human beings for security
purposes.

(H)
The director may, upon application thereof or upon his
or her own initiative, grant a variance to the requirements of rules as he or
she determines is authorized by law, provided that the registrant shows to the
satisfaction of the director that there is good cause for the variance, and
that the variance will not result in any undue hazard or effect on the public
health and safety or environment. The terms, conditions, and expiration of the
variance shall be set forth in writing by the director. Failure to comply with
the terms of the variance may result in immediate revocation of the
variance.